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The efficacy of reduced form of coenzyme Q10 in the Treatment of dementia (The efficacy of reduced form of coenzyme Q10 in the Treatment of dementia)

Coenzyme Q10 for dementia (Coenzyme Q10 for dementia)

44

The median and range of age of the participants were 81 (60-89) years, respectively. Randomization resulted in 15 participants in the active drug group (7 males and 8 females) and 14 participants in the placebo group (8 males and 6 females).

Forty-four patients were enrolled in the study, with 15 in the active drug group and 14 in the placebo group completing the one-year course of medication. Of the dropouts, 11 withdrew before taking the drug. The other dropouts were 2 patients who withdrew after 20 weeks and 2 patients who withdrew after 24 weeks. Medication compliance after initiation was good.

Side effects such as soft stools or diarrhea expected from the administration of the actual drug were not observed.

The primary endpoint was the pre- and post-treatment change in cognitive function as measured by the ADAS-Jcog neuropsychological test. Improvement was defined as a change from baseline to one year post-treatment of 0 or less, and the proportion of patients who improved from baseline to one year post-treatment was compared between two groups. The number of subjects who completed the treatment was 15 in the active drug group and 14 in the placebo group. Of these, one patient in the active drug group was excluded due to inappropriate post-test timing. In addition, one patient in the real drug group had a significant change in the ADAS-Jcog and was excluded from the analysis based on a rejection test. Finally, 13 patients in the active drug group and 14 patients in the placebo group were included in the analysis. The results of the Fisher exact test showed no superiority of the drug group (p > 0.05). Secondary endpoints included other neuropsychological tests (MMSE, Hasegawa's dementia scale, apathy scale, depression self-rating scale, frontal lobe function test, ADAS-Jcog) and head MRI (hippocampal atrophy, ratio of hippocampal atrophy to the whole brain). However, data on head MRI were missing in one subject in the active drug group, so 12 subjects in the actual drug group and 14 subjects in the placebo group were used in the analysis of MRI. The Wilcoxon rank-sum test was used to compare the change from pre-treatment to 12 months post-treatment, and no items showed significant differences between groups (ps > 0.05).

A randomized controlled trial was conducted to verify the effectiveness of ubiquinol for patients with mild to moderate dementia. Out of 44 participants, 29 completed the 12-month trial. The analysis was conducted on the valid data of 13 in the active drug group and 14 in the placebo group. There was no significant difference in the primary outcomes, and the superiority of ubiquinol was not demonstrated. Future clinical research plans utilizing the data from this study will be developed.

May. 31, 2025

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs061180062

ABE SATOSHI

Shimane University Hospital

89-1, Enya-cho, Izumo-shi, Shimane

sabe@med.shimane-u.ac.jp

ABE SATOSHI

Shimane University Hospital

89-1, Enya-cho, Izumo-shi, Shimane

+81-853-20-2197

sabe@med.shimane-u.ac.jp

Complete

Jan. 23, 2017

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

1) Diagnosis is one of five types of dementia.
Alzheimer disease, Vascular dementia, Dementia of Lewy Body, frontotemporal dementia, Mild Cognitive Impairment: (MCI)
2) Clinical Dementia Rating (CDR) is 0.5,1 or 2 (mild-moderate dementia).
3) Mini-Mental State Examination (MMSE) score is between 15 and 28.
4) Treatment has been kept with four drugs, donepezil, galantamine, rivastigmine, memantine and some other drug.
5) Agreement with clinical trial is between 50 and 89 years old.
6) A declaration of consent shall be valid if drawn up as a document providing sufficient evidence.

1) Metabolic encephalopathy (hypothyroidism, Vitamin B12 deficiency)
2) Post head trauma
3) Delirium due to any drugs
4) Alcohol abuse
5) Depression under medication
6) Mental disorder treated by antipsychotic drugs
7) Schizophrenia, mania, severe heart failure, and severe liver injury.
8) Chronic renal failure with creatinine clearance less than 20 ml/min.
9) Treated with malignancy
10) Investigator decides inappropriate for enrollment

Both

Dementia

Positive drug: Taking of reduced Coenzyme Q10 (300mg,6 capsules) per oral once a day for 12 months
Placebo drug: Taking of placebo capsules (increased base,6 capsules) per oral once a day for 12 months

Frequency of participants with change of ADAS-Jcog being less than zero after dose of reduced Coenzyme Q10 for 48 weeks

1) Change of ADAS-Jcog post 48 weeks dose of reduced Coenzyme Q10
2) Rate of clinically effective cases
3) Changes of neural network on functional MRI
4) Adverse event (frequency and degree of severity)
5) Comparison with choline esterase inhibitors and memantine

+81-853-20-2515

Feb. 05, 2019

none